10

Alternative medicine “butt” of serious joke

By
Michael
– December 15, 2010Posted in: Bad Science, Health, good journalism
If you wrote to the organising committee of a scientific conference saying that you have a theory that there is a person in everyone’s bum and if you massage it in the...

If you wrote to the organising committee of a scientific conference saying that you have a theory that there is a person in everyone’s bum and if you massage it in the right way, you can cure many illnesses, do you think you would be invited to give a paper to the conference?

Perhaps if you were invited, you might justifiably conclude that the discipline that the conference is in is a pile of rubbish. Or, at least, that the organisation that is hosting the conference is made up of a bunch of quacks.

Well, one professor of medical education in the UK proposed exactly this as a topic for a paper to a “Complementary and Alternative Medicines” conference in Jerusalem. And, to his surprise, he was invited to give a paper.

His conclusion is very nicely expressed:

So called integrative medicine should not be used as a way of smuggling alternative practices into rational medicine by way of lowered standards of critical thinking. Failure to detect an obvious hoax is not an encouraging sign.

He recounts the story in the British Medical Journal‘s Christmas edition, which is full of stuff that’s meant to be entertaining. His article is indeed entertaining and worth a read.

Check out his original pitch in which he subtly alludes to butt-kissing (“gentle suction”):

Recently, as a result of my developmental studies on human embryos, I have discovered a new version of reflexology, which identifies a homunculus represented in the human body, over the area of the buttocks. The homunculus is inverted, such that the head is represented in the inferior position, the left buttock corresponds to the right hand side of the body, and the lateral aspect is represented medially. As with reflexology, the “map” responds to needling, as in acupuncture, and to gentle suction, such as cupping. In my studies, responses are stronger and of more therapeutic value than those of auricular or conventional reflexology. In some cases, the map can be used for diagnostic purposes.

The idea of pulling a hoax to point out the absurdity of disciplines has a great history, which this hoaxster is aware of. He (somewhat self-flatteringly) compares his little stunt to the Sokal hoax in which Alan Sokal famously revealed the absurdity of postmodernist cultural studies by submitting a ridiculous paper to a respected journal and having it published.

If you haven’t read about the Sokal hoax, do some googling. Sokal has also recently written a book about the hoax and other related things that is on my summer reading list…

[Via Cardiology Update]

ResearchBlogging.org McLachlan JC (2010). Integrative medicine and the point of credulity. BMJ (Clinical research ed.), 341 PMID: 21147748

2

Mythbusting booze: Absorbing alcohol through feet?!?

By
Michael
– December 15, 2010Posted in: Health
Yeah — I didn’t think this was a belief that anyone held either. But apparently it’s Danish urban folklore that you can become drunk by submerging your feet in an...

Yeah — I didn’t think this was a belief that anyone held either. But apparently it’s Danish urban folklore that you can become drunk by submerging your feet in an alcoholic beverage. At least, that’s what three Danish researchers say in the British Medical Journal.

These three guys decided, in the spirit of early science, to test the putative myth on themselves.

They sat with their feet in a laundry tub full of vodka for three hours and measured their blood-alcohol levels every three hours.

Unsurprisingly, they found that there were no significant changes in blood alcohol levels and they provide the following sober conclusion.

Our results suggest that the transcutaneous intake of alcohol (vodka, 37.5% by volume) through feet is not possible. We therefore conclude that the Danish urban myth about being able to get drunk by submerging feet in strong alcoholic beverages is just that; a myth.

ResearchBlogging.org Christian Stevns Hansen, Louise Holmsgaard Færch, Peter Lommer Kristensen (2010). Testing the validity of the Danish urban myth that alcohol can be absorbed through feet: open labelled self experimental study The British Medical Journal : 10.1136/bmj.c6812

19

Doctors arguing badly: the ethics of placebos

By
Michael
– October 26, 2010Posted in: Bad Science, Health, philosophy
The ethics of conducting medical trials can be tricky. There is always the risk someone could be exposed to a drug that is dangerous, or they could miss out on...

The ethics of conducting medical trials can be tricky. There is always the risk someone could be exposed to a drug that is dangerous, or they could miss out on something of potential benefit.

So these issues need debating in medical journals.

But doctors and medical researchers are not ethicists and this was, I think, demonstrated by an article recently in the prominent journal The New England Journal of Medicine.

So bad was an argument made by these experts, that it’s really worth thinking about for a minute.

» The issue

The debate was about whether or not it is ethical to conduct placebo controlled trials of drugs that treat osteoporosis. The trouble is that we now have very good drugs that significantly reduce the rates of fractures, and giving someone a placebo is denying them something that will do them a great deal of good.

This problem needs to be weighed against the fact that controlled trials are needed to develop newer, better drugs. So, you can see that there is an issue here that needs to be debated.

One of the central questions, is whether there are alternative ways of trialling new drugs, without using placebos. One such way is to compare new drugs to existing drugs: “head-to-head trials”.

But the practical problem with conducting head-to-head trials is that they need to be much larger in order to show statistically significant effects.

» The good argument

In one article in the journal, two doctors said that this practical concern doesn’t matter.

The challenges associated with head-to-head trials “should not be considered an ethical justification for administering placebo to some patients, which would result in potentially preventable fractures,” they said.

This seems to me to be a good argument. The underlying principle is that the alternative to a course of action being practically difficult, doesn’t make that action ethical. Just because doing head-to-head trials is difficult doesn’t mean that giving people placebos is ethically OK.

» The bad argument

But the guys arguing that placebo trials can still be ethical in osteoporosis expected this argument, and rebutted it with what I think is one of the worst ethical arguments I have come across in a medical journal.

Ultimately, any trial involving [an active] comparison group would, given its necessarily larger size, result in more fractures over the duration of the trial than would be observed in a placebo-controlled study and, thus, it would offer no ethical advantage over the latter.

It seems to me that they’re defending the principle that the primary ethical consideration is the total number of negative outcomes observed in a trial.

That’s what they’re saying, right? Read it again:

…would, given its necessarily larger size, result in more fractures over the duration of the trial than would be observed in a placebo-controlled study and, thus, it would offer no ethical advantage over the latter.

But that is an absurd principle to defend. On the basis of that principle, if we were to do a large trial where we gave patients the very best care we know of, it could be unethical because if it’s large enough, it will observe a lot of negative outcomes.

Indeed, it would be an argument against collecting data on real-world outcomes in what are known as “observational studies”. If you observe a million people, then there will be lots of negative outcomes. But that clearly doesn’t make observing them unethical.

I put this point to the lead author in an email. I received a very nice and thoughtful reply, but I don’t think any light was shed on the matter. (I’ll post the reply in the comments.)

» The relevant ethical principle

Giving a placebo to 100 people, and seeing 5 negative outcomes is worse than giving best treatment to 100,000 people and seeing a few more negative outcomes.

The relevant issue is not the number of negative outcomes, but the risk of negative outcomes being imposed on each patient. It’s about the intervention we’re making, and whether that is ethical.

So we need to make sure we’re not giving people placebos when they could benefit from an active treatment and we need to make sure that active treatments we are trialling are likely to be safe and effective. We can never be sure, but with these matters, it’s always about the risk — the probability of harm.

ResearchBlogging.org Stein CM, & Ray WA (2010). The ethics of placebo in studies with fracture end points in osteoporosis. The New England journal of medicine, 363 (14) PMID: 20879888

ResearchBlogging.org Rosen CJ, & Khosla S (2010). Placebo-controlled trials in osteoporosis–proceeding with caution. The New England journal of medicine, 363 (14) PMID: 20879887

17

Another day, another drug company cover up

By
Michael
– October 15, 2010Posted in: Bad Science, Health
It seems that hardly a month goes by without another shocking example of drug companies hiding, manipulating or lying about data in order to mislead consumers about the safety or...

It seems that hardly a month goes by without another shocking example of drug companies hiding, manipulating or lying about data in order to mislead consumers about the safety or effectiveness of their products.

The big cases that have garnered media coverage around the world recently were Vioxx and Avandia. But there’s constantly smaller, equally shocking stories of how pharma cherry-pick data to exaggerate how great their drugs are.

This week, the British Medical Journal (BMJ) published some amazing research showing that a reasonably common antidepressant — reboxetine (Edronax) — is actually completely ineffective and possibly harmful. And, what’s more, the only reason it appeared to be effective in earlier meta-analyses, was because Pfizer, the dug’s manufacturer, was hiding data that showed it was ineffective!

What’s more, the only reason we thought it was equally as safe as other common antidepressants (like Prozac) was that Pfizer were hiding the evidence that it was more harmful.

But, you might ask, how exaggerated were the claims of  effectiveness?

Well, the German researchers calculated this by comparing what the published data said about the effectiveness of reboxetine, with what the pooled published and unpublished data said. The published data exaggerated the effectiveness by 115%. That is, it said it was more than twice as effective than it actually is, compared to placebo. (That means twice as likely to result in remission than it really was.)

It’s bad enough that Pfizer chose not to publish data that wasn’t positive about its shiny pill. But the real kicker to the story is that when the researchers initially approached Pfizer asking them for access to the data, they refused. Only after a report was published stating that there was no reliable evidence of the drug’s effectiveness, did Pfizer agree to hand over the data.

When they turned over all the raw data, the researchers uncovered biases in the published reports resulting from cherry-picking and biases between what trials were reported, and what were not.

As two editors of the BMJ said in an accompanying editorial, this kind of behaviour cannot be allowed. Compulsory preregistration of trials goes some way to solving the problem — it means that we know when trials are conducted, and not published. But to stop the biased analyses of the data, we need the raw data made publicly available.

I can’t help being surprised by the response pharmaceutical companies make when these revelations are made. Rather than saying “Yep, it looks like the drugs aren’t effective. We’ll withdraw them immediately,” or even, “Well, let’s wait a bit longer and see what the evidence says,” they almost always reply by saying that the drugs work fine.

GSK said it after it was revealed that they had fiddled with the evidence behind rosiglitazone (Avandia), Merck said it after Voixx and Pfizer are saying it now.

Until pharmaceutical policy is changed around the world, it really is going to be a matter of another day, another drug company cover-up. They’ll just keep getting away with it.

ResearchBlogging.org Godlee F, & Loder E (2010). Missing clinical trial data: setting the record straight. BMJ (Clinical research ed.), 341 PMID: 20940217

ResearchBlogging.org Eyding, D., Lelgemann, M., Grouven, U., Harter, M., Kromp, M., Kaiser, T., Kerekes, M., Gerken, M., & Wieseler, B. (2010). Reboxetine for acute treatment of major depression: systematic review and meta-analysis of published and unpublished placebo and selective serotonin reuptake inhibitor controlled trials BMJ, 341 (oct12 1) DOI: 10.1136/bmj.c4737

Latest Headlines
Older Entries